CELL & GENE THERAPY INSIGHTS

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Sep 2021. Vol 7 Issue 8

Sep 2021

FEATURING

Issue Spotlights: Scale-up and scale-out - what do we really need and how will we get there? | Gene therapy CMC and quality control
Focus: Global commercial strategies
Focus: Upstream Bioprocessing
Report: Innovation Insights August 2021

Other articles
Webinars

Spotlight

Gene therapy CMC and quality control
Oct 2021

Spotlight

Scale-up and scale-out - what do we really need and how will we get there?
Sep 2021

Foreword

Scale-up and scale-out: what do we really need and how will we get there?

Scale-up and scale-out: what do we really need and how will we get there?
Jan Thirkettle
15 October 2021
Foreword
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Editorial

Improving the yield of rAAV manufacturing with HeLa producer cells lines to ensure patient access

Improving the yield of rAAV manufacturing with HeLa producer cells lines to ensure patient access
Matthew Fuller
5 October 2021
Editorial
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Expert Insight

Scalable downstream process development for <em>in vivo</em> gene therapy products: understanding full/empty separation capabilities and challenges with ion exchange chromatography

Scalable downstream process development for in vivo gene therapy products: understanding full/empty separation capabilities and challenges with ion exchange chromatography
Kumar Dhanasekharan
29 September 2021
Expert Insight
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Innovator Insight

cGMP manufacturing made easy: a case study by ElevateBio

cGMP manufacturing made easy: a case study by ElevateBio
Michael Paglia,
Shannon Eaker
24 November 2021
Innovator Insight
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Scaling-up the production of stem cell-derived extracellular vesicles in stirred-tank bioreactors

Scaling-up the production of stem cell-derived extracellular vesicles in stirred-tank bioreactors
Aurélie Tacheny
29 September 2021
Innovator Insight
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Applying a closed, modular, semi-automated system to CAR T cell therapy manufacturing

Applying a closed, modular, semi-automated system to CAR T cell therapy manufacturing
Yongchang Ji
14 September 2021
Innovator Insight
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Interview

Reaping the benefits in scalability: the flexibility of an in-house gene therapy manufacturing strategy

Reaping the benefits in scalability: the flexibility of an in-house gene therapy manufacturing strategy
Alexandria Forbes, PhD
15 October 2021
Interview
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Scaling up viral vector production: the importance of quality

Scaling up viral vector production: the importance of quality
Jeffrey Lacouchie
5 October 2021
Interview
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Industrializing viral vector manufacture

Industrializing viral vector manufacture
Daniel Teasley,
Katherine Schewe
15 September 2021
Interview
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Expert Roundtable Video

Expert Roundtable: evolution in AAV process development: 2022 and beyond

Expert Roundtable: evolution in AAV process development: 2022 and beyond
Alejandro Becerra,
Matthias Hebben,
Michael Mercaldi
14 October 2021
Expert Roundtable Video
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Expert Roundtable: overcoming challenges in analytical assays for cellular therapies

Expert Roundtable: overcoming challenges in analytical assays for cellular therapies
Jara Joedicke,
Eric Alonzo, PhD,
Marsilius Mues
12 October 2021
Expert Roundtable Video
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Expert Roundtable

Expert Roundtable: evolution in AAV process development: 2022 and beyond

Expert Roundtable: evolution in AAV process development: 2022 and beyond
Alejandro Becerra,
Matthias Hebben,
Michael Mercaldi
15 October 2021
Expert Roundtable
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Expert Roundtable: overcoming challenges in analytical assays for cellular therapies

Expert Roundtable: overcoming challenges in analytical assays for cellular therapies
Jara Joedicke,
Eric Alonzo, PhD,
Marsilius Mues
14 October 2021
Expert Roundtable
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FastFacts

Cell and gene manufacturing: a case study approach to overcoming challenges – understanding the value of an expert supplier

Cell and gene manufacturing: a case study approach to overcoming challenges – understanding the value of an expert supplier
Sean Werner,
Adam Shields
4 October 2021
FastFacts
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Getting closer to the in vivo environment with human AB serum

Getting closer to the in vivo environment with human AB serum
Trevor Smith
31 August 2021
FastFacts
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Viewpoint

From start-up to scale-up: a journey through AAV process development

From start-up to scale-up: a journey through AAV process development
Kevin Mouillesseaux
5 October 2021
Viewpoint
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Viral vector gene delivery: balancing safety, efficacy and dose

Viral vector gene delivery: balancing safety, efficacy and dose
Thijs Gerritzen
1 October 2021
Viewpoint
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Supply Chain FOCUS

Global commercial strategies

Interview

Evolution and innovation in autologous cell therapy supply chain

Evolution and innovation in autologous cell therapy supply chain
Sadia L’Baouch
18 August 2021
Interview
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On Demand Webinar

Importance of high-quality starting material for success in advanced therapy

Importance of high-quality starting material for success in advanced therapy
Bob Amareld,
Nathan Frank, MS,
Jason C Lin,
Richard McFarland,
John Paul Tomtishen III
12 August 2021
On Demand Webinar
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Vectors FOCUS

Upstream Bioprocessing

Innovator Insight

Key considerations for maximizing LV and AAV production in transient transfection workflows

Key considerations for maximizing LV and AAV production in transient transfection workflows
Leisha Kopp,
Beth Larimore,
Nolan Sutherland,
Anindya Dasgupta
8 October 2021
Innovator Insight
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Utilizing a media panel rapidly accelerates media optimization for AAV manufacturers

Utilizing a media panel rapidly accelerates media optimization for AAV manufacturers
Céline Martin,
Jennifer Zatina
28 September 2021
Innovator Insight
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Scalability comparison between 50 and 500 liter stirred tank bioreactor for production of rAAV viral vector

Scalability comparison between 50 and 500 liter stirred tank bioreactor for production of rAAV viral vector
Todd P Sanderson,
Timothy Erlandson,
Nathan Hazi,
Anne MacIntyre,
Benjamin I Ingersoll,
Michael McLaughlin,
Steven Wesel,
Phillip B Maples
23 September 2021
Innovator Insight
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Evaluation of a microbioreactor system as a screening tool for optimizing lentiviral vector process development in suspension culture

Evaluation of a microbioreactor system as a screening tool for optimizing lentiviral vector process development in suspension culture
Nolan Sutherland,
Lesley Chan,
Kelly Kral,
Franziska Bollmann
22 September 2021
Innovator Insight
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Transfer and scale-up from 10 L BioBLU<sup>®️</sup> to Allegro™ STR 50 and STR 200 Bioreactors

Transfer and scale-up from 10 L BioBLU®️ to Allegro™ STR 50 and STR 200 Bioreactors
David Mainwaring,
Amar Joshi,
Juliana Coronel,
Christian Niehus
25 November 2021
Innovator Insight
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Commentary

Enabling development of commercial-ready lentiviral vector manufacturing processes using stable producer cell lines

Enabling development of commercial-ready lentiviral vector manufacturing processes using stable producer cell lines
Peter Archibald, Ph.D,
Anthony Shillings
22 September 2021
Commentary
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FastFacts

Development of a scalable AAV production process in suspension cells

Development of a scalable AAV production process in suspension cells
Ann-Christin Magnusson
11 November 2021
FastFacts
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Leveraging lessons from the COVID-19 pandemic to accelerate the development and production of viral-based gene therapies

Leveraging lessons from the COVID-19 pandemic to accelerate the development and production of viral-based gene therapies
Yasser Kehail
5 October 2021
FastFacts
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Achieving cost-effective, scalable high-titer AAV production

Achieving cost-effective, scalable high-titer AAV production
Chao Yan Liu
30 September 2021
FastFacts
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Addressing HEK293 cell lineage and AAV diversity with media panel

Addressing HEK293 cell lineage and AAV diversity with media panel
Jennifer Schieber
29 September 2021
FastFacts
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Scale up of a lentiviral production process from the iCELLis<sup>®️</sup> Nano Bioreactor to the iCELLis 500+ Bioreactor

Scale up of a lentiviral production process from the iCELLis®️ Nano Bioreactor to the iCELLis 500+ Bioreactor
Isabelle Pelletier,
Kaitlynn Bayne
22 September 2021
FastFacts
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Scalable cell culture and transient transfection for viral vector manufacturing

Scalable cell culture and transient transfection for viral vector manufacturing
Ann Rossi Bilodeau PhD
20 September 2021
FastFacts
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Viewpoint

Overview of major AAV production platforms

Overview of major AAV production platforms
Jote Bulcha
24 September 2021
Viewpoint
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Report

Innovation Insights August 2021

Interview

Broadening horizons for extracellular vesicles as both therapeutic modality and delivery tool

Broadening horizons for extracellular vesicles as both therapeutic modality and delivery tool
Joana Correia
17 August 2021
Interview
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Evolving technology trends and regulatory pathways in the tissue engineered product space

Evolving technology trends and regulatory pathways in the tissue engineered product space
William Fodor
17 August 2021
Interview
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Other articles

FastFacts

Adenovirus vector manufacturing platform using CIMmultus™️ QA assures the supply of safe vaccines

Adenovirus vector manufacturing platform using CIMmultus™️ QA assures the supply of safe vaccines
Hana Jug
4 October 2021
FastFacts
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Webinars

Cell-based therapies for cancer treatment: leveraging advanced flow cytometry for greater clinical insight

Cell-based therapies for cancer treatment: leveraging advanced flow cytometry for greater clinical insight
Nina Senutovitch Ph.D.
Nina Senutovitch Ph.D., Senior Scientist, Product Development, Cell Imaging, Sartorius
Professor Rong Fan
Professor Rong Fan, Professor of Biomedical Engineering, Yale University
Tamara J. Laskowski, Ph.D.
Tamara J. Laskowski, Ph.D., Scientific Project Director, Adoptive Cell Therapy Platform, Dept. of Stem Cell Transplantation and Cellular Therapy MD Anderson Cancer Center
5 August 2021
Webinar
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Midstream unit operations: Unsung heroes in AAV process development

Midstream unit operations: Unsung heroes in AAV process development
Matthew Roach
Matthew Roach, AAV Process Development Team Leader, Precision BioSciences
Ratish Krishnan
Ratish Krishnan, Senior Strategy Consultant, Novel Modalities BioProcessing Group, Merck
18 August 2021
Webinar
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The setup and payoff: entering the clinic and the market efficiently by leveraging a platform lentiviral vector process

The setup and payoff: entering the clinic and the market efficiently by leveraging a platform lentiviral vector process
Kevin D Beck, PhD
Kevin D Beck, PhD, Associate Director of Account Management, Miltenyi Biotec
1 September 2021
Webinar
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AAV manufacturing with stable producer cells for industrial scale vector production

AAV manufacturing with stable producer cells for industrial scale vector production

Ben Hudjetz, PhD
Ben Hudjetz, PhD, Senior Scientist, Cell Line Development, CEVEC Pharmaceuticals GmbH
16 September 2021
Webinar
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Get your non-viral T cell engineering process ready for clinical manufacturing

Get your non-viral T cell engineering process ready for clinical manufacturing
Melanie Rietenbach
Melanie Rietenbach, Global Product Manager Miltenyi Biotec
Stefan Wild
Stefan Wild, Senior Manager, Research and Development, Miltenyi Biotec
Kunal Patel
Kunal Patel, Process Engineering Manager, Miltenyi Biotec
21 September 2021
Webinar
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GMP manufacturing for exosome-based therapies: the critical role of analytics and process design for clinical production and scale-up

GMP manufacturing for exosome-based therapies: the critical role of analytics and process design for clinical production and scale-up
Marcos Langtry
Marcos Langtry, Head of Allogeneic Cell Therapy Commercial Development, Lonza Pharma & Biotech
Davide Zocco
Davide Zocco, Research & Development Senior Manager, Lonza Pharma & Biotech
28 September 2021
Webinar
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cGMP manufacturing made easy – a case study by ElevateBio

cGMP manufacturing made easy – a case study by ElevateBio
Michael Paglia
Michael Paglia, COO, ElevateBio, BaseCamp
Shannon Eaker
Shannon Eaker, Cell and Gene Therapy Enterprise Solutions and FastTrak Leader, Cytiva
14 October 2021
Webinar
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Optimization of AAV production for high-yielding and scalable GMP processes

Optimization of AAV production for high-yielding and scalable GMP processes
Claire Wartel-Weill
Claire Wartel-Weill, Director, Quality & Compliance
Mathieu Porte
Mathieu Porte, BioProduction R&D Manager, Polyplus-transfection
Bhargavi Kondragunta
Bhargavi Kondragunta, Director of Internal R&D & Product Development, Catalent
George Buchman, PhD
George Buchman, PhD, Vice President, Pre-Clinical and Process Development, Catalent Cell & Gene Therapy
20 October 2021
Webinar
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Considerations for developing scalable and efficient collection network processes

Considerations for developing scalable and efficient collection network processes
Lacey Anderson
Lacey Anderson, Senior Manager, Collection Network Management, Be The Match BioTherapies
Sara Butler
Sara Butler, Network Liaison, Be The Match BioTherapies
Allison Montalvo,
Allison Montalvo, , Program Manager, Oncology, Janssen ( A division of J&J)
28 October 2021
Webinar
Watch now